usrds annual data report appendices, 2018...glossary acute kidney injury (aki) also known as acute...

Abbreviations

AAPCC Adjusted average per capita cost

ACEI angiotensin-converting enzyme inhibitor

ACR albumin/creatinine ratio

ADL activities of daily living

ADR annual data report

AF atrial fibrillation

AFIB atrial fibrillation

AFS Annual Facility Survey (CMS 2744)

AJKD American Journal of Kidney Disease

AKI acute kidney injury

AKI-D acute kidney injury with dialysis

AMI acute myocardial infarction

ANZDATA Australia & New Zealand ESRD database

ARB angiotensin receptor blocker

ASHD atherosclerotic heart disease

AV arteriovenous

BMI body mass index

BUN blood urea nitrogen

CABG coronary artery bypass grafting

CAPD continuous ambulatory peritoneal dialysis

CBC complete blood count

CCPD continuous cycling peritoneal dialysis

CDC Centers for Disease Control and Prevention

CDM Clinformatics DataMart

CDS Comprehensive Dialysis Study

CES-D Center for Epidemiologic Studies Depression Scale

CKD chronic kidney disease

CKD-EPI chronic kidney disease epidemiology calculation

CKO cytokinin oxidase

CMS Centers for Medicare & Medicaid Services

CMV cytomegalovirus (antibody status)

COPD chronic obstructive pulmonary disease

CORR Canadian Organ Replacement Register

CPM clinical performance measures

CPRA calculated panel reactive bodies

CPT current procedure and terminology

CrCl creatinine clearance rate

CROWNWeb Consolidated Renal Operations in a Web-Enabled Network (CROWN) Data — data collection system for ESRD dialysis facilities mandated by CMS

CRT cardiac resynchronization

CVA cerebrovascular accident

CVD cardiovascular disease

CVVHD continuous venous-to-venous hemodialysis

CWF common working file

DCD donation after circulatory death

DCI Dialysis Clinic, Inc.

DFC dialysis facility compare

DGF delayed graft function

DHD daily hemodialysis

DM diabetes mellitus

DME durable medical equipment

DMMS Dialysis Morbidity and Mortality Study

DPO darbepoetin alfa

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Abbreviations

DRG diagnosis related group

DSA Donation Service Area [or Disability Services Agency]

DUA data use agreement

ECD expanded criteria donor

EDB Enrollment Database

eGFR estimated glomerular filtration rate

EGHP employer group health plan

EPO erythropoietin

ESA erythropoiesis stimulating agent

ESRD end-stage renal disease

FSD first service date

GFR glomerular filtration rate

GLIMMIX A SAS procedure

GN glomerulonephritis

HbA1c glycosylated hemoglobin

HB hospital-based

HCFA Health Care Financing Administration (CMS before July 2001)

HCPCS healthcare common procedure coding system

HD hemodialysis

HDL high density lipoprotein

HEDIS Health Plan Employer Data Information Set

HF Heart failure

Hgb hemoglobin

HHA home health agency

HIC health insurance claims

HIC/BIC Health Insurance Claim/Beneficiary Identification Code

HIPAA Health Insurance Portability and Accountability Act

HLA Human leukocyte antigen

HRSA Health Resources and Services Administration

HS hospice

HSA Health Service Area

HTN hypertension

ICD-9 International Classification of Diseases, 9th revision

ICD-9-CM International Classification of Diseases, 9th revision, Clinical Modification

ICD-10 International Classification of Diseases, 10th revision

ICD-10-CM International Classification of Diseases, 10th revision, Clinical Modification

ICD implantable cardioverter defibrillator

ICD/CRT-D implantable cardioverter defibrillator/cardiac resynchronization therapy with defibrillator device

ICW intracellular water

IHD intermittent hemodialysis

IL2-RA interleukin 2 receptor alpha

IP inpatient

IPD intermittent peritoneal dialysis

IRB Institutional Review Board

ISHD ischemic heart disease

IV intravenous

KDIGO Kidney Disease Improving Global Outcomes

KDOQI Kidney Disease Outcomes Quality Initiative

LDL low density lipoprotein

LDO large dialysis organization

LIS low income subsidy

MCBS Medicare Current Beneficiary Survey

MDRD Modification of Diet in Renal Disease

MI myocardial infarction

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2018 USRDS Annual Data Report | Appendices

MPP Medicare as primary payer

MSP Medicare as secondary payer

mTOR mammalian (or mechanistic) target of rapamycin

NCHS National Center for Health Statistics

NCQA National Committee for Quality Assurance

NEJM New England Journal of Medicine

NHANES National Health and Nutrition Examination Survey

NHIS National Health Interview Survey

NIDDK National Institute of Diabetes and Digestive and Kidney Diseases

NKF National Kidney Foundation

OMB Office of Management and Budget

OOP out-of-pocket

OP outpatient

OPTN Organ Procurement and Transplantation Network

PACE programs of all-inclusive care for the elderly

PAD peripheral arterial disease

PCI percutaneous coronary intervention

PD peritoneal dialysis

PDE prescription drug event

PDP prescription drug plan

PII patient identifiable information

PMMIS Program Medical Management and Information System

PPPM per person per month

PPPY per person per year

PPS prospective payment system

PRA panel reactive antibodies

pts patients

PTLD post-transplant lymphoproliferative disorder

PVD peripheral vascular disease

QI qualifying individuals

QMB qualified Medicare beneficiaries

RBC red blood cells

REBUS Renal Beneficiary and Utilization System

REMIS Renal Management Information System

rhGH recombinant human growth hormone

RRB Railroad Retirement Board

SAF standard analysis file

SAS Statistical Analysis System

SCA/VA Sudden cardiac arrest and ventricular arrhythmias

SCD sudden cardiac death

SCD standard criteria donor

SDO small dialysis organization

SHR standardized hospitalization ratio

SMR standardized mortality ratio

SNF skilled nursing facility

SSA Social Security Administration

SSI Supplemental Security Income

SSRI selective serotonin reuptake inhibitor

STR standardized transplantation rate

STrR standardized transfusion ratio

TBW total body weight

THMS Truven Health Market Scan

TIA transient ischemic attack

TrOOP true out-of-pocket costs

Tx transplant

TZD thiazolidinedione

UNOS United Network for Organ Sharing

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Abbreviations

URR urea reduction ratio

USRDS United States Renal Data System

VA vascular access

VAT vascular access type

WHO World Health Organization

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Glossary

Acute kidney injury (AKI) Also known as acute kidney failure or acute renal failure. A sudden decline in renal function triggered by any of a number of conditions such as shock, trauma, drug toxicity, acute glomerulonephritis, vasculitis, or obstruction to urine flow.

Acute myocardial infarction (AMI) An event causing death to a portion of the heart muscle due to lack of blood supply.

Adult polycystic kidney disease An inherited disease in which normal kidney tissue is replaced by multiple cysts.

Albumin/creatinine ratio (ACR) A screening test used to estimate the amount of albumin in a patient’s urine.

Anemia A condition marked by a reduced number of red cells in the bloodstream.

Angiography A radiographic procedure where a radio-opaque contrast material is injected into a blood vessel for the purpose of identifying its anatomy.

Angioplasty A procedure in which a balloon catheter is inserted into a blocked or narrowed vessel to reopen the vessel and allow normal blood flow.

Angiotensin converting enzyme (ACE) inhibitor An antihypertensive agent that inhibits the conversion of angiotensin I to angiotensin II. Can delay progression of kidney disease in diabetics.

Angiotensin II receptor blocker (ARB) An antihypertensive agent that inhibits the actions of angiotensin II, a substance that causes constriction of blood vessels.

Arteriovenous fistula A type of vascular access used in hemodialysis patients and created by the anastomosis of an artery and a vein.

Arteriovenous graft A type of vascular access used in hemodialysis patients and created via a connection between an artery and vein using either a native vessel (e.g. saphenous vein) or a synthetic material.

Beta blockers Antihypertensive medications that block β-adrenergic receptors, thus interfering with the actions of endogenous catecholamines (epinephrine and norepinephrine), slowing the heart rate and reducing the constriction of blood vessels.

Blood urea nitrogen (BUN) A by-product of the breakdown of amino acids and endogenous and ingested protein.

Body mass index (BMI) A measure of height to weight ratio: weight (kg)/height (m2).

C-reactive protein A protein produced by theliver in response to infection or inflammation;high levels are associated with an increased risk of heart disease and stroke.

Calcium channel blockers Antihypertensive agents that work by blocking the access of calcium to muscle cells in artery walls.

Cardiac arrest A sudden complete cessation of cardiac activity.

Cardiac resynchronization therapy defibrillator (CRT-D) An implantable device designed to arrest the fibrillation of heart muscle by applying an electric shock, thus depolarizing the heart cells and allowing normal rhythm to return.

Cardiomyopathy A general diagnostic term indicating a disease of the heart muscle.

Catastrophic coverage Health insurance to cover costs that exceed routine healthcare insurance benefits.

Coronary artery disease (CAD) A disease of the arteries of the heart, characterized by a thickening and narrowing and/or loss of elasticity of the arterial walls due to plaque deposition.

Centers for Disease Control & Prevention (CDC) The lead federal agency for protectingthe health and safety of people at home andabroad; develops and applies programsdesigned to improve the health of the people ofthe United States.

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Glossary

Centers for Medicare & Medicaid Services (CMS) Formerly the Health Care Financing Administration (HCFA). Federal agency that administers the Medicare, Medicaid, and State Childrens’ Health insurance programs.

Cerebrovascular accident (CVA) A general descriptor that encompasses such problems as stroke and cerebral hemorrhage.

Cerebrovascular disease A disease that causes narrowing or occlusion of the arteries supplying blood to the brain.

Chain provider A single business entity that at year’s end owns or operates 20 or more freestanding dialysis units. This definition applies to all chain affiliation references in the USRDS Annual Data Reports. An alternative definition from the Centers for Medicare & Medicaid Services (CMS) can be found under “definitions” in the Health Care Provider/ Supplier Application Form, CMS 855.

Chronic kidney disease (CKD) A condition in which there is a progressive loss of kidney function which over time; may lead to end-stage renal disease.

Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation A method used to estimate glomerular filtration rate using a single serum creatinine. Yields a lower CKD prevalence than the Modification of Diet in Renal Disease (MDRD) Study equation.

Chronic obstructive pulmonary disease (COPD) One of a number of classes of chronic progressive lung diseases.

Clinical Performance Measures (CPM) Project Formerly the Core Indicator Project. A project in which CMS and the ESRD networks cooperatively maintain a clinical database of key elements related to the quality of dialysis care. These elements are used as indicators in quality improvement initiatives.

Common Working File (CWF) System The Medicare inpatient/outpatient and physician/supplier benefit coordination and claims validation system. Under the CWF System, CMS maintains both institutional and physician/supplier claims-level data. CWF

claims records are the data source for most claims and utilization files used by the USRDS.

Comprehensive Dialysis Study (CDS) A special data collection study that focuses on physical activity level, health-related quality of life, and work/disability status reported by patients who have recently started maintenance dialysis.

Continuous ambulatory peritoneal dialysis (CAPD) A type of dialysis in which dialysate is continuously present in the abdominal cavity. Fluid is exchanged using gravity to fill and empty the cavity 4–5 times a day.

Continuous cycling peritoneal dialysis (CCPD) A type of dialysis in which the abdominal cavity is filled and emptied of dialysate using an automated cycler machine.

Coverage gap The interval in a prescription drug plan beginning once initial benefits are exhausted, but preceding catastrophic coverage.

Creatinine A waste product of protein metabolism found in the urine. Blood creatinine concentration is an indirect measure of kidney function. Abnormally high creatinine levels indicate kidney failure or renal insufficiency.

Creatinine clearance A measure of kidney function.

Creditable coverage Prescription drug coverage that is actuarially equivalent to the standard Part D benefit, as defined annually by CMS. Beneficiaries with creditable coverage may forgo participation in Medicare Part D without having to pay increased monthly premiums upon future enrollment. Examples of creditable coverage include the Federal Employee Health Benefits Program, TRICARE, VA Health Care Benefits, State Pharmacy Assistance Programs (SPAPs), and private insurance eligible for the retiree drug subsidy. Private insurance for the working aged may or may not be creditable.

Cystatin-C equation A method for estimating glomerular filtration rate (GFR) that uses the laboratory marker cystatin-C.

Heart failure (HF) A condition caused by impaired pumping of the heart and consequent fluid accumulation in the lungs.

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Darbepoetin alfa (DPO) One of a class of medications called erythropoietic proteins. Used to treat anemia in patients with serious kidney disease.

Death Notification Form (CMS-2746) A form submitted following the death of an ESRD patient containing basic patient demographic information in addition to information on the primary cause of death.

Dialysis catheter A type of vascular access used in hemodialysis patients, commonly implanted into the jugular or subclavian vein.

Employer group health plan (EGHP) A health plan of or contributed to by an employer, providing medical care directly or through other methods such as insurance or reimbursement to current or former employees, or to these employees and their families.

End-stage renal disease (ESRD) A condition in which a person’s kidney function is inadequate to support life.

Erythropoiesis stimulating agent (ESA) Used to increase the production of red blood cells; includes erythropoietin (EPO) and darbepoetin alfa (DPO).

Erythropoietin (EPO) A hormone secreted chiefly by the adult kidney; acts on bone marrow to stimulate red cell production. Also produced in a formulated version to treat anemia.

ESRD Facility Survey Data for this survey are collected annually by CMS from all facilities certified to provide Medicare-covered renal dialysis and transplantation. The survey uses CMS form 2744 and encompasses the full calendar year. Geographic data are included to the level of facility ZIP code. Each record contains facility information and data on the number of patients served, dialysis treatments provided, and kidney transplants performed. The data include services to both Medicare and non-Medicare patients.

ESRD Networks Regional organizations, established by law in 1978, contracted by CMS to perform quality oversight activities to

assure the appropriateness of services and protection for dialysis patients.

Expanded criteria donor (ECD) A kidney donor over the age of 60 years, or between the ages of 50 and 59 years, with two of the following criteria: death by CVA, history of hypertension or creatinine at time of recovery (terminal creatinine) ≥ 1.5 mg/dL.

Fills per person Each prescription drug purchase constitutes a fill. Fills per person are calculated from the quotient of cumulative fills in a population and the number of people in that population.

Glomerular filtration rate (GFR) Rate in ml/ min/1.73 m2 of the volume of plasma filtered by the kidney. Rates of filtration may be measured directly or estimated based on formulae that employ combinations of an individual’s age, gender, and height, and on levels of serum creatinine, blood urea nitrogen, and serum albumin. GFR is traditionally considered the best overall index to determine renal function.

Glycosylated hemoglobin (HbA1c) A laboratory test measuring the percentage of hemoglobin-bound glucose in the bloodstream to help determine how well a patient’s diabetes is being controlled.

Health Maintenance Organization (HMO) An organization that provides or arranges managed care on a prepaid basis.

Health Service Area (HSA) A group of counties described by the authors of the CDC Atlas of United States Mortality as “an area that is relatively self-contained with respect to hospital care.”

Healthy People 2020 A national agenda for health promotion and disease prevention, with objectives and goals aimed at improving the health of the American people (www.health.gov/ healthypeople).

Hemodialysis The process of removing toxins from the blood by diffusion through a semi-permeable membrane.

Hemoglobin Oxygen-carrying protein in the erythrocyte (red blood cell).

Hepatitis An inflammation of the liver that may be caused by a viral infection, poisons, or the

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http://www.health.gov/healthypeople

Glossary

use of alcohol or other drugs. Forms include Hepatitis A, usually transmitted by contaminated food or water; Hepatitis B, transmitted through blood and body fluids; and Hepatitis C, also transmitted through blood and body fluids.

Hospital-based facility A dialysis unit attached to or located in a hospital and licensed to provide outpatient dialysis services directly to ESRD patients.

Implantable cardioverter defibrillator (ICD) An implantable device designed to arrest the fibrillation of heart muscle by applying electric shock, thus depolarizing the heart cells and allowing normal rhythm to return.

Incident ESRD patient A patient starting renal replacement therapy for ESRD. Excludes patients with acute renal failure, those with chronic renal failure who die before starting ESRD treatment, and those whose treatments are not reported to CMS.

Incident population The people in a population who are newly diagnosed with a disease in a given time period, typically a year.

Independent unit A unit licensed to provide outpatient and home maintenance dialysis that is not affiliated with a chain.

Initial coverage period The interval following the deductible phase, but preceding the coverage gap.

Ischemic heart disease (ISHD) A disease of the heart evidenced by a lowered oxygen supply to the heart tissue, caused by occlusion or narrowing of the arteries supplying the heart muscle.

Kidney Disease Outcomes Quality Initiative (KDOQI) Established in 1995 by the National Kidney Foundation to improve patient outcomes and survival by providing recommendations for optimal clinical practices in the areas of dialysis adequacy, vascular access, and anemia.

Kt/V A unitless number used to quantify clearance of small molecular weight substances (solutes) such as urea, where K = dialyzer clearance of urea, t = dialysis time and V = volume of distribution of urea

(approximately equal to the total body water). It reflects the degree of removal of these substances during dialysis treatment, and is expressed by Kt/V per hemodialysis session or weekly Kt/V in the context of peritoneal dialysis.

Low-income subsidy (LIS) LIS helps people with Medicare pay for prescription drugs, and lowers the costs of Medicare prescription drug coverage.

Medical Evidence form (CMS-2728) A form that provides source data about ESRD patients, including information on demographics, primary cause of renal disease, comorbidities, biochemical data, dialysis treatment, transplant, dialysis training, employment status, initial insurance coverage, and first ESRD service date.

Medicare Advantage Part D plan (MA-PD) A Medicare Part D plan offered only to participants in Medicare Part C.

Medicare as Secondary Payer (MSP) patient A Medicare beneficiary with a health insurer other than Medicare (e.g. an Employer Group Health Plan) having primary responsibility for payment of the beneficiary’s medical bills.

Medicare Current Beneficiary Survey (MCBS) A continuous, multipurpose survey of a nationally representative sample of the Medicare population, conducted by the Office of Enterprise Data and Analytics (OEDA) of the Centers for Medicare & Medicaid Services (CMS) through a contract with NORC at the University of Chicago. The central goals of the MCBS are to determine expenditures and sources of payment for all services used by Medicare beneficiaries, including co-payments, deductibles, and non-covered services; to ascertain all types of health insurance coverage and relate coverage to sources of payment; and to trace outcomes over time, such as changes in health status and spending down to Medicaid eligibility and the impacts of Medicare program changes on satisfaction with care and usual source of care.

Microalbuminuria A condition in which small amounts of albumin are present in the urine; indicates early kidney damage.

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Modality A method of treatment. Treatment for end-stage renal disease (ESRD) is comprised of three modalities: hemodialysis, peritoneal dialysis, and transplantation.

Modification of Diet in Renal Disease (MDRD) Study equation A method used to estimate glomerular filtration (GFR) in patients with impaired renal function using a single serum creatinine, age, sex and race.

National Health and Nutrition Examination Survey (NHANES) A survey conducted by the National Center for Health Statistics (NCHS) at the Centers for Disease Control and Prevention that uses home interviews and health tests to collect information on health and diet in the United States.

National Institutes of Health (NIH) The federal focal point for medical research in the U.S. and one of eight health agencies of the Public Health Services, which are part of the Department of Health and Human Services.

Organ Procurement and Transplantation Network (OPTN) The unified transplant network established by the United States Congress under the National Organ Transplant Act (NOTA) of 1984. A private, non-profit organization administered by the United Network for Organ Sharing, under contract with the Health Resources and Services Administration of the U.S. Department of Health and Human Services.

Part D Medicare coverage A U.S. government program which subsidizes the costs of medications for Medicare beneficiaries.

Percutaneous coronary intervention (PCI) A therapeutic procedure to treat stenotic (narrowed) coronary arteries of the heart found in coronary heart disease. Commonly known as coronary angioplasty or simply angioplasty.

Period prevalent patient A patient receiving treatment for ESRD at some point during a period of time, usually six months or a year. Patients may die during the period or be point prevalent at the end of the period. Period prevalence is a useful measure for cost analysis, since it indicates total disease burden over the course of a year.

Peripheral vascular disease (PVD) A progressive disease causing narrowing or occlusion of the arteries.

Peritoneal dialysis A treatment for kidney failure in which fluid (dialysate) is introduced into the abdominal cavity and uremic toxins are removed by diffusion across the peritoneum.

Point prevalent patient A patient reported as receiving treatment for ESRD on a particular day of the calendar year (e.g. December 31).

Program Medical Management and Information System for ESRD, and Renal Beneficiary and Utilization System (PMMIS/REBUS) The major source of data for the USRDS. This CMS file incorporates data from the Medical Evidence form (CMS 2728), the Death Notification form (CMS 2746), the Medicare Enrollment Database, CMS paid claims records, and the OPTN transplant database.

Prevalent ESRD patient A patient on renal replacement therapy or with a functioning kidney transplant (regardless of the transplant date). This definition excludes patients with acute renal failure, those with chronic renal failure who die before receiving treatment for ESRD, and those whose ESRD treatments are not reported to CMS.

Prevalent population The people in a population who have a disease at a given point in time (point prevalence) or during a given time period (period prevalence).

Proteinuria The existence of protein in the urine; indicative of kidney damage.

Recombinant human growth hormone (rhGH) Also called somatropin; a substance identical in its amino acid sequence to human growth hormone and used to treat growth hormone deficiency.

Renal Management Information System (REMIS) CMS’s Oracle relational database system that replaced the Renal Beneficiary and Utilization System (REBUS) in 2003. REMIS included an operational interface to the Standard Information Management System (SIMS) Central Repository until 2012, at which point CROWNWeb replaced the functionality of SIMS.

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Glossary

Renin inhibitors A class of drugs used to lower blood pressure by blocking the renin-angiotensin system, which regulates blood volume and systemic vascular resistance.

Retiree drug subsidy (RDS) A program designed to encourage employers to continue providing prescription drug coverage to retirees eligible for Medicare Part D. Under the program, employers received a tax-free rebate equal to 28% of covered prescription drug costs incurred by their retirees. While relatively simple to administer, RDS may ultimately be more costly than providing employees a type of Part D plan known as an “employer group waiver plan.” Following passage of the Patient Protection and Affordable Care Act, the tax-free status of the subsidy expired on December 31, 2012.

Standard Information Management System (SIMS) A component of CROWNWeb, an integrated information management system for the ESRD program that was replaced by CROWNWeb in 2012. SIMS supports CMS reporting requirements and the business processes of the ESRD networks; provides communication and data exchange links for the networks, CMS, and other parts of the renal community; supplies standard core data functionality for previous network data systems; and provides improved electronic communication capabilities, data standardization, and information management tools.

Standard Analysis Files (SAFs) CMS files containing final action Medicare inpatient/outpatient claims data: Inpatient, Outpatient, Home Health Agency, Hospice, Skilled Nursing Facility, Clinical Laboratory, Durable Medical Equipment, and 5 percent Sample Beneficiary.

Standardized hospitalization ratio (SHR) Used to compare hospitalization rates for a selected group of patients by computing the ratio of the group’s observed hospitalization rate to the expected hospitalization rate for the national ESRD population.

Standardized mortality ratio (SMR) Used to compare patient mortality rates for a selected

group of patients by computing the ratio of the group’s observed mortality rate to the expected mortality rate for the national ESRD population.

Standardized transplantation ratio (STR) Used to compare transplant rates for a subgroup of patients to national transplant rates, by computing the ratio of the group’s observed transplant rate to the expected transplant rate for the national ESRD population.

Statins Medications that lower cholesterol through inhibition of the HMG CoA enzyme.

Total days supply Each prescription drug is disbursed in sufficient quantity for administration over a set number of days, so long as instructions are followed. The total days supplied is equal to the cumulative number of days supplied through all fills of a particular medication in a population.

Transient ischemic attack (TIA) A temporary loss of neurological function caused by a brief period of inadequate blood supply in a portion of the brain.

United Network for Organ Sharing (UNOS) A private, non-profit organization that holds the Organ Procurement and Transplantation Network contract to maintain the national organ transplant waiting lists and coordinates the matching and distribution of organs to patients awaiting transplant.

Urea reduction ratio (URR) A means of measuring dialysis efficiency by calculating the change in blood urea nitrogen (BUN) over the course of a dialysis treatment. URR = (pre-dialysis – post-dialysis BUN) / pre-dialysis BUN * 100.

Vintage Time during which a patient has had ESRD.

Waiting list A list of patients awaiting an organ transplant that is maintained by UNOS and OPTN.

Some definitions from U.S. National Library of Medicine’s Medical Encyclopedia, https://medlineplus.gov/encyclopedia.html

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2018 USRDS ANNUAL DATA REPORT | APPENDICES 1

United States Renal Data System (USRDS) Agreement for Release of Data

Project Title __________________________________________________________________________________________

In this agreement, “Requester Organization” means _____________________________________________

A. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), through theUnited States Renal Data System (USRDS) Coordinating Center, will provide the Requester dataextracted from the USRDS research database (the “Data”), via download or on DVDs or othermedia type, which constitutes a Limited Dataset within the meaning of the HIPAA privacyregulations.

B. The sole purpose of providing the Data is the conduct of legitimate and approved biomedical,cost-effectiveness, and/or other economic research by the Requester.

C. The Requester shall not use the Data to identify individual beneficiaries or individual providers onthe files.

D. The Requester shall not combine or link the Data provided with any other collection or sourceof information that may contain information specific to individuals on the files, except where awaiver of authorization has been approved by the Requester’s IRB/Privacy Board and NIDDK.

E. The Requester shall not use the Data for purposes that are not related to biomedical research,cost-effectiveness, economic and/or other epidemiological research. Purposes for which theData may not be used include, but are not limited to,

• the identification and targeting of under- or over-served health service marketsprimarily for commercial benefit

• the obtaining of information about providers or facilities for commercial benefit• insurance purposes such as redlining areas deemed to offer bad health insurance risks• adverse selection (e.g., identifying patients with high risk diagnoses).

Any use of the Data for research not in the original proposal must be approved by the USRDS Project Officer (PO).

F. The Requester shall not publish or otherwise disclose the Data in the files to any person ororganization unless the Data have been aggregated (that is, combined into groupings of Datasuch that the Data are no longer specific to any individuals within each grouping), and no cells(aggregates of Data) contain information on fewer than eleven individuals or fewer than fiveproviders or facilities. The Requester shall not publish or otherwise disclose Data that identifyindividual providers or facilities, or from which such identities could be inferred. However, the

USRDS AGREEMENT FOR RELEASE OF DATA


Requester may release Data to a contractor for purposes of data processing or storage if (1) the Requester specified in the research plan submitted to the USRDS Project Officer that Data would be released to the particular contractor, or the Requester has obtained written authorization from the PO to release the Data to such contractor, and (2) the contractor has signed a data release agreement with the PO.

G. A copy of any aggregation of Data intended for publication shall be submitted to the PO for review for compliance with the confidentiality provisions of this agreement prior to submission for publication and, if not approved, shall not be published until compliance is achieved. The PO must respond within 30 days. The Approval Request Checklist may be found at: https://www.usrds.org/2018/appx/USRDS_Manuscript_Approval_Request_Checklist.pdf

H. Appropriate administrative, technical, procedural, and physical safeguards shall be established by the Requester to protect the confidentiality of the Data and to prevent unauthorized access to it. The safeguards shall provide a level of security outlined in OMB Circular No. A-130, Appendix III — Security of Federal Automated Information Resources, which sets forth guidelines for security plans for automated information systems in Federal agencies.

I. No copies or derivatives shall be made of the Data in these files except as necessary for the purpose authorized in this agreement. The Requester shall keep an accurate written account of all such copies and derivative files, which will be furnished upon request to the PO. The USRDS Data files covered in this data use agreement (DUA) may be retained by the Requester until the date specified by the PO in the approval letter, at which time Requester may request renewal of this data use agreement to extend the retention period to comply with legal or institutional recordkeeping requirements or to maintain the integrity of the research or research publications. If at any time during the data retention period the DUA between USRDS and CMS is canceled, the Requester will be contacted to destroy the files in their possession. At the completion of the activities in the research plan, the file(s) and any derivative files and copies shall be destroyed. At that time, the Requester will inform the USRDS and the PO in writing that the files have been destroyed.

J. For the purpose of inspecting security procedures and arrangements, authorized representatives of the NIDDK and/or of CMS will, upon request, be granted access to premises where the Data are kept.

https://www.usrds.org/2018/appx/USRDS_Manuscript_Approval_Request_Checklist.pdf



K. The following USRDS Data file(s) is/are covered under this Agreement.

Standard Analysis Files (SAFs) requested: ☐ Core ☐ Dialysis Morbidity and Mortality Study (DMMS) ☐ Transplant ☐ Comprehensive Dialysis Study (CDS) ☐ Hospital ☐ Clinical Performance Measures (CPM) ☐ CKD 5% Cohort Core ☐ Case Mix Adequacy (CMA) ☐ CKD 5% Cohort Hospital ☐ Active-Adipose Study (AAS)

☐ CROWNWeb Clinical Data ☐ Transition of Care in CKD (TCCKD)

For the following SAFs, indicate the claim year(s) requested as well:

☐ Institutional Claims (pre-1989 through 2016 available) _______________________________

☐ Medicare Claims Clinical data (2011-2016) _______________________________

☐ Physician/Supplier Claims (1991–2016 available) _______________________________

☐ Part D (2006–2016 available) _______________________________

☐ Pre-ESRD Institutional Claims (incident years 1995-2016) _______________________________

☐ Pre-ESRD Physician/Supplier Claims (incident years 1995-2016) _______________________________

☐ Pre-ESRD Part D (incident years 2008-2016) _______________________________

☐ CKD 5% Institutional Claims (1992–2016 available) _______________________________

☐ CKD 5% Physician/Supplier Claims (1992–2016 available) _______________________________

☐ CKD 5% Part D (2006–2016 available) _______________________________

Crosswalks:

☐ Provider Crosswalk ☐ Physician Crosswalk ☐ UNOS Crosswalk*

*UNOS – United Network for Organ Sharing. Requester must provide proof of UNOS data approval & patient identifiers to link with USRDSID

_________________________________________________________________________________________________________________ Requester Signature (for the Institutional Official for Data Assurance)

_________________________________________________________________________________________________________________ Authorized Signatory (name, title & date)

_________________________________________________________________________________________________________________ Requester Address

_________________________________________________________________________________________________________________ Requester Telephone Number



Read and Acknowledged (for Primary Investigator and all co-investigators who will analyze data directly)

_____________________________________________ _______________________________________ __________________ Investigator / Analyst signature Name Date




(attach additional signature pages as necessary)

USRDS Project Officer: Kevin C. Abbott, MD, NIDDK, NIH, [email protected] USRDS Project Officer Signature Date

Checklist: DID YOU REMEMBER TO SEND:

☐ Signed copy of your institutional IRB approval memo

☐ Copy of your project proposal in recommended format at http://www.usrds.org/2018/appx/3/Outline_for_Research_Proposals_Using_USRDS_Data.pdf

☐ Copy of this Data Use Agreement signed by your institutional official, PI, and all active participants.

Please note that any MODIFICATIONS or AMENDMENTS, regardless of whether they require additional files, require a new IRB approval memo, copy of the original project proposal with additional analyses/extractions highlighted, and a new signed Data Use Agreement (bulleted items listed above). Please send ALL documents (including the research protocol) in PDF format AND consolidate all files into a single PDF file (using the “PDF Portfolio” feature in Adobe) when sending to the NIDDK.

05/01/2019 revision

mailto:[email protected]

http://www.usrds.org/2017/appx/3/Outline_for_Research_Proposals_Using_USRDS_Data.pdf


United States Renal Data System (USRDS) Merged Dataset Agreement for Release of Data

Project Title __________________________________________________________________________________________

In this agreement, “Requester Organization” means _____________________________________________

A. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), through the

United States Renal Data System (USRDS) Coordinating Center, will provide the Requester data

extracted from the USRDS research database (the “Data”), via download or on DVDs or other

media type, which constitutes a Limited Dataset within the meaning of the HIPAA privacy

regulations. Prior to receiving USRDS data, the Requester will provide USRDS with a list of

personally identifiable information (PII) so USRDS can report which of the Requester’s subjects

are in the USRDS end-stage renal disease (ESRD) data.

B. The sole purpose of providing the Data is the conduct of legitimate and approved biomedical,

cost-effectiveness, and/or other economic research by the Requester.

C. USRDS shall not use or disclose the Requester’s data for any purpose other than to create the

Data extracted from the USRDS database. In the event that the Requester’s data is used or

disclosed for any purpose other than that covered by this agreement, USRDS will notify the

Requester immediately and agree to work with Requester to address the use or disclosure. The

USRDS will destroy the Requester’s dataset one year after the linkage is complete unless

otherwise specified by the Requester in the research proposal.

D. The Requester shall not combine or link the Data provided with any other collection or source

of information that may contain information specific to individuals on the files, except where a

waiver of authorization has been approved by the Requester’s IRB/Privacy Board and NIDDK.

E. The Requester shall not use the Data for purposes that are not related to biomedical research,

cost-effectiveness, economic and/or other epidemiological research. Purposes for which the

Data may not be used include, but are not limited to,

the identification and targeting of under- or over-served health service markets primarily

for commercial benefit

the obtaining of information about providers or facilities for commercial benefit

insurance purposes such as redlining areas deemed to offer bad health insurance risks

adverse selection (e.g., identifying patients with high risk diagnoses)

Any use of the Data for research not in the original proposal must be approved by the USRDS

Project Officer (PO).

F. The Requester shall not publish or otherwise disclose the Data in the files to any person or

organization unless the Data have been aggregated (that is, combined into groupings of Data

USRDS MERGED DATASET AGREEMENT FOR RELEASE OF DATA


such that the Data are no longer specific to any individuals within each grouping), and no cells

(aggregates of Data) contain information on fewer than eleven individuals or fewer than five

providers or facilities. The Requester shall not publish or otherwise disclose Data that identify

individual providers or facilities, or from which such identities could be inferred. However, the

Requester may release Data to a contractor for purposes of data processing or storage if (1) the

Requester specified in the research plan submitted to the USRDS Project Officer that Data would

be released to the particular contractor, or the Requester has obtained written authorization

from the PO to release the Data to such contractor, and (2) the contractor has signed a data

release agreement with the PO.

G. A copy of any aggregation of Data intended for publication shall be submitted to the PO for

review for compliance with the confidentiality provisions of this agreement prior to submission

for publication and, if not approved, shall not be published until compliance is achieved. The PO

must respond within 30 days.

The Approval Request Checklist may be found at:


H. Appropriate administrative, technical, procedural, and physical safeguards shall be established

by the Requester to protect the confidentiality of the Data and to prevent unauthorized access

to it. The safeguards shall provide a level of security outlined in OMB Circular No. A-130,

Appendix III — Security of Federal Automated Information Resources, which sets forth

guidelines for security plans for automated information systems in Federal agencies.

I. No copies or derivatives shall be made of the Data in these files except as necessary for the

purpose authorized in this agreement. The Requester shall keep an accurate written account of

all such copies and derivative files, which will be furnished upon request to the PO. The USRDS

Data files covered in this data use agreement (DUA) may be retained by the Requester until the

date specified by the PO in the approval letter, at which time Requester may request renewal of

this data use agreement to extend the retention period to comply with legal or institutional

recordkeeping requirements or to maintain the integrity of the research or research

publications. If at any time during the data retention period the DUA between USRDS and CMS is

canceled, the Requester will be contacted to destroy the files in their possession. At the

completion of the activities in the research plan, the file(s) and any derivative files and copies

shall be destroyed. At that time, the Requester will inform the USRDS and the PO in writing that

the files have been destroyed.

J. For the purpose of inspecting security procedures and arrangements, authorized

representatives of the NIDDK and/or of CMS will, upon request, be granted access to premises

where the Data are kept.




K. The following USRDS Data file(s) is/are covered under this Agreement.

Standard Analysis Files (SAFs) requested:

☐ Core ☐ Dialysis Morbidity and Mortality Study (DMMS)

☐ Transplant ☐ Comprehensive Dialysis Study (CDS)

☐ Hospital ☐ Clinical Performance Measures (CPM)

☐ CKD 5% Cohort Core ☐ Case Mix Adequacy (CMA)

☐ CKD 5% Cohort Hospital ☐ Active-Adipose Study (AAS)

☐ CROWNWeb Clinical Data ☐ Transition of Care in CKD (TCCKD)

For the following SAFs, indicate the claim year(s) requested, as well:

☐ Institutional Claims (pre-1989 through 2016 available) _______________________________

☐ Medicare Claims Clinical Data (2011-2016) _______________________________

☐ Physician/Supplier Claims (1991–2016 available) _______________________________

☐ Part D (2006–2016 available) _______________________________

☐ Pre-ESRD Institutional Claims (incident years 1995-2016) _______________________________

☐ Pre-ESRD Physician/Supplier Claims (incident years 1995-2016) _______________________________

☐ Pre-ESRD Part D (incident years 2008-2016) _______________________________

☐ CKD 5% Institutional Claims (1992–2016 available) _______________________________

☐ CKD 5% Physician/Supplier Claims (1992–2016 available) _______________________________

☐ CKD 5% Part D (2006–2016 available) _______________________________

Crosswalks:

☐ Provider Crosswalk ☐ Physician Crosswalk ☐ UNOS Crosswalk*

*UNOS – United Network for Organ Sharing. Requester must provide proof of UNOS data approval & patient identifiers to link with USRDSID

IMPORTANT! Specify:

☐Data ONLY on matched patients OR

☐Complete SAFs, including matched and unmatched patients

_________________________________________________________________________________________________________________ Requester Signature (for the Institutional Official for Data Assurance)

_________________________________________________________________________________________________________________ Authorized Signatory (name, title & date)

_________________________________________________________________________________________________________________ Requester Address

_________________________________________________________________________________________________________________ Requester Telephone Number



Read and Acknowledged (for Primary Investigator and all co-investigators who will analyze data directly)





(attach additional signature pages as necessary)

USRDS Project Officer: Kevin C. Abbott, MD, NIDDK, NIH, [email protected]

USRDS Project Officer Signature Date

Checklist: DID YOU REMEMBER TO SEND:

☐ Signed copy of your institutional IRB approval memo

☐ Copy of your project proposal in recommended format at

http://www.usrds.org/2018/appx/3/Outline_for_Research_Proposals_Using_Merged_USRDS_Data.pdf

☐ Copy of this Data Use Agreement signed by your institutional official, PI, and all active

participants. Please note that any MODIFICATIONS or AMENDMENTS, regardless of whether they require additional files, require a new IRB approval memo, copy of the original project proposal with additional analyses/extractions highlighted, and a new signed Data Use Agreement (bulleted items listed above). Please send ALL documents (including the research protocol) in PDF format AND consolidate all files

into a single PDF file (using the “PDF Portfolio” feature in Adobe) when sending to the NIDDK.

05/01/2019 revision

mailto:[email protected]

http://www.usrds.org/2018/appx/3/Outline_for_Research_Proposals_Using_Merged_USRDS_Data.pdf

___ ___ ___

___ ___ ___

___ ___

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved CENTERS FOR MEDICARE & MEDICAID SERVICES OMB No. 0938-0046

END STAGE RENAL DISEASE MEDICAL EVIDENCE REPORT MEDICARE ENTITLEMENT AND/OR PATIENT REGISTRATION

A. COMPLETE FOR ALL ESRD PATIENTS Check one: Initial Re-entitlement Supplemental1. Name (Last, First, Middle Initial)

2. Medicare Claim Number 3. Social Security Number 4. Date of Birth

MM DD YYYY

5. Patient Mailing Address (Include City, State and Zip) 6. Phone Number

( )

7. Sex

Male Female

8. Ethnicity

Not Hispanic or Latino Hispanic or Latino (Complete Item 9)

9. Country/Area of Origin or Ancestry

10. Race (Check all that apply)White AsianBlack or African American American Indian/Alaska Native

Native Hawaiian or Other Pacific Islander*

Print Name of Enrolled/Principal Tribe _________________ *complete Item 9

11. Is patient applying for ESRDMedicare coverage?

Yes No

12. Current Medical Coverage (Check all that apply)Medicaid Medicare Employer Group Health Insurance DVA Medicare Advantage Other None

13. HeightINCHES _______ OR

CENTIMETERS _______

14. Dry WeightPOUNDS _______ OR

KILOGRAMS _______

15. Primary Cause of RenalFailure (Use code from back of form)

16. Employment Status (6 mos prior andcurrent status)

UnemployedEmployed Full Time Employed Part Time HomemakerRetired due to Age/Preference Retired (Disability) Medical Leave of Absence Student

roirP

tnerruC

a. Congestive heart failure n. Malignant neoplasm, Cancerb. Atherosclerotic heart disease ASHD o. Toxic nephropathyc. Other cardiac disease p. Alcohol dependenced. Cerebrovascular disease, CVA, TIA* q. Drug dependence*e. Peripheral vascular disease* r. Inability to ambulatef. History of hypertension s. Inability to transfer

g. Amputation t. Needs assistance with daily activitiesh. Diabetes, currently on insulin u. Institutionalizedi. Diabetes, on oral medications 1. Assisted Livingj. Diabetes, without medications 2. Nursing Home

k. Diabetic retinopathy 3. Other Institutionl. Chronic obstructive pulmonary disease v. Non-renal congenital abnormality

m. Tobacco use (current smoker) w. None

17. Co-Morbid Conditions (Check all that apply currently and/or during last 10 years) *See instructions

18. Prior to ESRD therapy:a. Did patient receive exogenous erythropoetin or equivalent?b. Was patient under care of a nephrologist?c. Was patient under care of kidney dietitian?d. What access was used on first outpatient dialysis:

If not AVF, then: Is maturing AVF present? Is maturing graft present?

Yes Yes Yes AVF Yes Yes

NoNoNoGraftNoNo

Unknown If Yes, answer: 6-12 months >12 months Unknown If Yes, answer: 6-12 months >12 months Unknown If Yes, answer: 6-12 months >12 months Catheter Other

19. Laboratory Values Within 45 Days Prior to the Most Recent ESRD Episode. (Lipid Profile within 1 Year of Most Recent ESRD Episode).

a.1. Serum Albumin (g/dl) d. HbA1c___ . ___ ___ ___ . ___% a.2. Serum Albumin Lower Limit e. Lipid Profile TC___ . ___

LDLa.3. Lab Method Used (BCG or BCP)

b. Serum Creatinine (mg/dl) HDL___ ___ . ___ c. Hemoglobin (g/dl) TG ___ ___ . ___ B. COMPLETE FOR ALL ESRD PATIENTS IN DIALYSIS TREATMENT20. Name of Dialysis Facility

22. Primary Dialysis SettingHome Dialysis Facility/Center SNF/Long Term Care Facility

24. Date Regular Chronic Dialysis BeganMM DD YYYY

26. Has patient been informed of kidney transplant options?Yes No

21. Medicare Provider Number (for item 20)

23. Primary Type of DialysisHemodialysis (Sessions per week____/hours per session____) CAPD CCPD Other

25. Date Patient Started ChronicDialysis at Current Facility MM DD YYYY

27. If patient NOT informed of transplant options, please check all that apply:Medically unfit Patient declines information Unsuitable due to age Patient has not been assessed Psychologically unfit Other

FORM CMS-2728-U3 (06/04) EF(03/2005)

LABORATORY TEST VALUE DATE LABORATORY TEST VALUE DATE

755

C. COMPLETE FOR ALL KIDNEY TRANSPLANT PATIENTS28. Date of Transplant 29. Name of Transplant Hospital 30. Medicare Provider Number for Item 29

MM DD YYYY

Date patient was admitted as an inpatient to a hospital in preparation for, or anticipation of, a kidney transplant prior to the date of actual transplantation. 31. Enter Date

MM DD YYYY

32. Name of Preparation Hospital 33. Medicare Provider number for Item 32

34. Current Status of Transplant (if functioning, skip items 36 and 37) Functioning Non-Functioning

35. Type of Donor:Deceased Living Related Living Unrelated

36. If Non-Functioning, Date of Return to Regular Dialysis

MM DD YYYY

37. Current Dialysis Treatment SiteHome Dialysis Facility/Center SNF/Long Term Care Facility

D. COMPLETE FOR ALL ESRD SELF-DIALYSIS TRAINING PATIENTS (MEDICARE APPLICANTS ONLY)38. Name of Training Provider

40. Date Training Began

MM DD YYYY

42. This Patient is Expected to Complete (or has completed) Trainingand will Self-dialyze on a Regular Basis.

Yes No

39. Medicare Provider Number of Training Provider (for Item 38)

41. Type of Training Hemodialysis a. Home b. In Center

CAPD CCPD Other43. Date When Patient Completed, or is Expected to Complete, Training

MM DD YYYY

I certify that the above self-dialysis training information is correct and is based on consideration of all pertinent medical, psychological, and sociological factors as reflected in records kept by this training facility. 44. Printed Name and Signature of Physician personally familiar with the patient’s training 45. UPIN of Physician in Item 44

a.) Printed Name b.) Signature c.) Date MM DD YYYY

E. PHYSICIAN IDENTIFICATION

46. Attending Physician (Print) 47. Physician’s Phone No. 48. UPIN of Physician in Item 46

( )PHYSICIAN ATTESTATION

I certify, under penalty of perjury, that the information on this form is correct to the best of my knowledge and belief. Based on diagnostic tests and laboratory findings, I further certify that this patient has reached the stage of renal impairment that appears irreversible and permanent and requires a regular course of dialysis or kidney transplant to maintain life. I understand that this information is intended for use in establishing the patient’s entitlement to Medicare benefits and that any falsification, misrepresentation, or concealment of essential information may subject me to fine, imprisonment, civil penalty, or other civil sanctions under applicable Federal laws.

49. Attending Physician’s Signature of Attestation (Same as Item 46) 50. Date

MM DD YYYY

51. Physician Recertification Signature 52. Date

MM DD YYYY

53. Remarks

F. OBTAIN SIGNATURE FROM PATIENT

I hereby authorize any physician, hospital, agency, or other organization to disclose any medical records or other information about my medical condition to the Department of Health and Human Services for purposes of reviewing my application for Medicare entitlement under the Social Security Act and/or for scientific research. 54. Signature of Patient (Signature by mark must be witnessed.) 55. Date

MM DD YYYY

G. PRIVACY STATEMENTThe collection of this information is authorized by Section 226A of the Social Security Act. The information provided will be used to determine if an individual is entitled to Medicare under the End Stage Renal Disease provisions of the law. The information will be maintained in system No. 09-70-0520, “End Stage Renal Disease Program Management and Medical Information System (ESRD PMMIS)”, published in the Federal Register, Vol. 67, No. 116, June 17, 2002, pages 41244-41250 or as updated and republished. Collection of your Social Security number is authorized by Executive Order 9397. Furnishing the information on this form is voluntary, but failure to do so may result in denial of Medicare benefits. Information from the ESRD PMMIS may be given to a congressional office in response to an inquiry from the congressional office made at the request of the individual; an individual or organization for research, demonstration, evaluation, or epidemiologic project related to the prevention of disease or disability, or the restoration or maintenance of health. Additional disclosures may be found in the Federal Register notice cited above. You should be aware that P.L.100-503, the Computer Matching and Privacy Protection Act of 1988, permits the government to verify information by way of computer matches.

FORM CMS-2728-U3 (06/04) EF(03/2005)

756

LIST OF PRIMARY CAUSES OF END STAGE RENAL DISEASE

Item 15. Primary Cause of Renal Failure should be completed by the attending physician from the list below. Enter the ICD-9-CM code to indicate the primary cause of end stage renal disease. If there are several probable causes of renal failure, choose one as primary. Code effective as of September 2003.

DIABETES25040 Diabetes with renal manifestations Type 2 25041 Diabetes with renal manifestations Type 1

GLOMERULONEPHRITIS5829 Glomerulonephritis (GN)

(histologically not examined) 5821 Focal glomerulosclerosis, focal sclerosing GN 5831 Membranous nephropathy 58321 Membranoproliferative GN type 1, diffuse MPGN 58322 Dense deposit disease, MPGN type 2 58381 IgA nephropathy, Berger’s disease

(proven by immunofluorescence) 58382 IgM nephropathy (proven by immunofluorescence) 5834 With lesion of rapidly progressive GN 5800 Post infectious GN, SBE 5820 Other proliferative GN

SECONDARY GN/VASCULITIS

CYSTIC/HEREDITARY/CONGENITAL DISEASES 75313 Polycystic kidneys, adult type (dominant) 75314 Polycystic, infantile (recessive) 75316 Medullary cystic disease, including nephronophthisis 7595 Tuberous sclerosis 7598 Hereditary nephritis, Alport’s syndrome 2700 Cystinosis2718 Primary oxalosis 2727 Fabry’s disease 7533 Congenital nephrotic syndrome 5839 Drash syndrome, mesangial sclerosis 75321 Congenital obstruction of ureterpelvic junction 75322 Congenital obstruction of uretrovesical junction 75329 Other Congenital obstructive uropathy 7530 Renal hypoplasia, dysplasia, oligonephronia 75671 Prune belly syndrome 75989 Other (congenital malformation syndromes)

NEOPLASMS/TUMORS

7100 Lupus erythematosus, (SLE nephritis) 2870 Henoch-Schonlein syndrome 7101 Scleroderma28311 Hemolytic uremic syndrome 4460 Polyarteritis4464 Wegener’s granulomatosis 58392 Nephropathy due to heroin abuse and related drugs 44620 Other Vasculitis and its derivatives 44621 Goodpasture’s syndrome 58391 Secondary GN, other

INTERSTITIAL NEPHRITIS/PYELONEPHRITIS

HYPERTENSION/LARGE VESSEL DISEASE 40391 Unspecified with renal failure 4401 Renal artery stenosis 59381 Renal artery occlusion 59383 Cholesterol emboli, renal emboli

1890 Renal tumor (malignant) 1899 Urinary tract tumor (malignant) 2230 Renal tumor (benign) 2239 Urinary tract tumor (benign) 23951 Renal tumor (unspecified) 23952 Urinary tract tumor (unspecified) 20280 Lymphoma of kidneys 20300 Multiple myeloma 20308 Other immuno proliferative neoplasms

(including light chain nephropathy) 2773 Amyloidosis99680 Complications of transplanted organ unspecified 99681 Complications of transplanted kidney 99682 Complications of transplanted liver 99683 Complications of transplanted heart 99684 Complications of transplanted lung 99685 Complications of transplanted bone marrow 99686 Complications of transplanted pancreas 99687 Complications of transplanted intestine 99689 Complications of other specified transplanted organ

9659 Analgesic abuse 5830 Radiation nephritis 9849 Lead nephropathy 5909 Nephropathy caused by other agents 27410 Gouty nephropathy 5920 Nephrolithiasis5996 Acquired obstructive uropathy 5900 Chronic pyelonephritis, reflux nephropathy 58389 Chronic interstitial nephritis 58089 Acute interstitial nephritis 5929 Urolithiasis27549 Other disorders of calcium metabolism

MISCELLANEOUS CONDITIONS 28260 Sickle cell disease/anemia 28269 Sickle cell trait and other sickle cell (HbS/Hb other) 64620 Post partum renal failure 042 AIDS nephropathy 8660 Traumatic or surgical loss of kidney(s) 5724 Hepatorenal syndrome 5836 Tubular necrosis (no recovery) 59389 Other renal disorders 7999 Etiology uncertain

FORM CMS-2728-U3 (06/04) EF(03/2005)

757

FORM CMS-2728-U3 (08/15) 1

DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES

END STAGE RENAL DISEASE MEDICAL EVIDENCE REPORT MEDICARE ENTITLEMENT AND/OR PATIENT REGISTRATION

Form Approved OMB No. 0938-0046

A. COMPLETE FOR ALL ESRD PATIENTS Check one: Initial Re-entitlement Supplemental 1. Name (Last, First, Middle Initial)

2. Medicare Claim Number 3. Social Security Number 4. Date of Birth (mm/dd/yyyy)

5. Patient Mailing Address (Include City, State and Zip) 6. Phone Number (including area code)

7. Sex

Male Female

8. Ethnicity

Not Hispanic or Latino Hispanic or Latino (Complete Item 9)

9. Country/Area of Origin or Ancestry

10. Race (Check all that apply)White Asian Black or African American Native Hawaiian or Other Pacific Islander* American Indian/Alaska Native *complete Item 9

Print Name of Enrolled/Principal Tribe

11. Is patient applying forESRD Medicare coverage?

Yes No

12. Current Medical Coverage (Check all that apply)Medicaid Medicare Employer Group Health InsuranceDVA Medicare Advantage Other None

13. Height INCHES OR

CENTIMETERS

14. Dry WeightPOUNDS OR KILOGRAMS

15. Primary Cause of RenalFailure (Use ICD-10-CM Code)

16. Employment Status (6 mos prior andcurrent status)

Unemployed Employed Full Time Employed Part Time Homemaker Retired due to Age/Preference Retired (Disability) Medical Leave of Absence Student

17. Co-Morbid Conditions (Check all that apply currently and/or during last 10 years) *See instructionsa. Congestive heart failure n. Malignant neoplasm, Cancerb. Atherosclerotic heart disease ASHD o. Toxic nephropathy c. Other cardiac disease p. Alcohol dependence d. Cerebrovascular disease, CVA, TIA* q. Drug dependence* e. Peripheral vascular disease* r. Inability to ambulate f. History of hypertension s. Inability to transfer g. Amputation t. Needs assistance with daily activities h. Diabetes, currently on insulin u. Institutionalizedi. Diabetes, on oral medications 1. Assisted Livingj. Diabetes, without medications 2. Nursing Homek. Diabetic retinopathy 3. Other Institutionl. Chronic obstructive pulmonary disease v. Non-renal congenital abnormality m. Tobacco use (current smoker) w. None

18. Prior to ESRD therapy:a. Did patient receive exogenous erythropoetin or equivalent? Yes No Unknown If Yes, answer: <6 months 6-12 months >12 months b. Was patient under care of a nephrologist? Yes No Unknown If Yes, answer: <6 months 6-12 months >12 months c. Was patient under care of kidney dietitian? Yes No Unknown If Yes, answer: d. What access was used on first outpatient dialysis: AVF Graft Catheter Other

<6 months 6-12 months >12 months

If not AVF, then: Is maturing AVF present? Yes No Is maturing graft present? Yes No

19. Laboratory Values Within 45 Days Prior to the Most Recent ESRD Episode. (Lipid Profile within 1 Year of Most Recent ESRD Episode).LABORATORY TEST VALUE DATE LABORATORY TEST VALUE DATE

a.1. Serum Albumin (g/dl) d. HbA1c %

a.2. Serum Albumin Lower Limit e. Lipid Profile TCa.3. Lab Method Used (BCG or BCP) LDL b. Serum Creatinine (mg/dl) HDL c. Hemoglobin (g/dl) TG

B. COMPLETE FOR ALL ESRD PATIENTS IN DIALYSIS TREATMENT20. Name of Dialysis Facility 21. Medicare Provider Number (for item 20)

22. Primary Dialysis Setting

Home Dialysis Facility/Center SNF/Long Term Care Facility

23. Primary Type of Dialysis

Hemodialysis (Sessions per week /hours per session ) CAPD CCPD Other

24. Date Regular Chronic Dialysis Began (mm/dd/yyyy) 25. Date Patient Started Chronic Dialysis at Current Facility (mm/dd/yyyy)

26. Has patient been informedof kidney transplant options?

Yes No

27. If patient NOT informed of transplant options, please check all that apply:

Medically unfit Patient declines information Unsuitable due to age Patient has not been assessed Psychologically unfit Other

758

FORM CMS-2728-U3 (08/15) 2

C. COMPLETE FOR ALL KIDNEY TRANSPLANT PATIENTS28. Date of Transplant (mm/dd/yyyy) 29. Name of Transplant Hospital 30. Medicare Provider Number for Item 29

Date patient was admitted as an inpatient to a hospital in preparation for, or anticipation of, a kidney transplant prior to the date of actual transplantation. 31. Enter Date (mm/dd/yyyy) 32. Name of Preparation Hospital 33. Medicare Provider number for Item 32

34. Current Status of Transplant (if functioning, skip items 36 and 37)Functioning Non-Functioning

35. Type of Donor:Deceased Living Related Living Unrelated

36. If Non-Functioning, Date of Return to Regular Dialysis (mm/dd/yyyy) 37. Current Dialysis Treatment SiteHome Dialysis Facility/Center SNF/Long Term Care Facility

D. COMPLETE FOR ALL ESRD SELF-DIALYSIS TRAINING PATIENTS (MEDICARE APPLICANTS ONLY)38. Name of Training Provider 39. Medicare Provider Number of Training Provider (for Item 38)

40. Date Training Began (mm/dd/yyyy) 41. Type of TrainingHemodialysis a. Home b. In CenterCAPD CCPD Other

42. This Patient is Expected to Complete (or has completed) Trainingand will Self-dialyze on a Regular Basis.

Yes No

43. Date When Patient Completed, or is Expected to Complete, Training(mm/dd/yyyy)

I certify that the above self-dialysis training information is correct and is based on consideration of all pertinent medical, psychological, and sociological factors as reflected in records kept by this training facility.

44. Printed Name and Signature of Physician personally familiar with the patient’s training 45. UPIN of Physician in Item 44

a.) Printed Name b.) Signature c.) Date (mm/dd/yyyy)

E. PHYSICIAN IDENTIFICATION46. Attending Physician (Print) 47. Physician’s Phone No. (include Area Code) 48. UPIN of Physician in Item 46

PHYSICIAN ATTESTATION I certify, under penalty of perjury, that the information on this form is correct to the best of my knowledge and belief. Based on diagnostic tests and laboratory findings, I further certify that this patient has reached the stage of renal impairment that appears irreversible and permanent and requires a regular course of dialysis or kidney transplant to maintain life. I understand that this information is intended for use in establishing the patient’s entitlement to Medicare benefits and that any falsification, misrepresentation, or concealment of essential information may subject me to fine, imprisonment, civil penalty, or other civil sanctions under applicable Federal laws. 49. Attending Physician’s Signature of Attestation (Same as Item 46) 50. Date (mm/dd/yyyy)

51. Physician Recertification Signature 52. Date (mm/dd/yyyy)

53. Remarks

F. OBTAIN SIGNATURE FROM PATIENT

I hereby authorize any physician, hospital, agency, or other organization to disclose any medical records or other information about my medical condition to the Department of Health and Human Services for purposes of reviewing my application for Medicare entitlement under the Social Security Act and/or for scientific research. 54. Signature of Patient (Signature by mark must be witnessed.) 55. Date (mm/dd/yyyy)

G. PRIVACY STATEMENT

The collection of this information is authorized by Section 226A of the Social Security Act. The information provided will be used to determine if an individual is entitled to Medicare under the End Stage Renal Disease provisions of the law. The information will be maintained in system No. 09-70- 0520, “End Stage Renal Disease Program Management and Medical Information System (ESRD PMMIS)”, published in the Federal Register, Vol. 67, No. 116, June 17, 2002, pages 41244-41250 or as updated and republished. Collection of your Social Security number is authorized by Executive Order 9397. Furnishing the information on this form is voluntary, but failure to do so may result in denial of Medicare benefits. Information from the ESRD PMMIS may be given to a congressional office in response to an inquiry from the congressional office made at the request of the individual; an individual or organization for research, demonstration, evaluation, or epidemiologic project related to the prevention of disease or disability, or the restoration or maintenance of health. Additional disclosures may be found in the Federal Register notice cited above. You should be aware that P.L.100-503, the Computer Matching and Privacy Protection Act of 1988, permits the government to verify information by way of computer matches.

759

Form CMS‐2728‐U3 (08/15) 3

INSTRUCTIONS FOR COMPLETION OF END STAGE RENAL DISEASE MEDICAL EVIDENCE REPORT MEDICARE ENTITLEMENT AND/OR PATIENT REGISTRATION

For whom should this form be completed:

This form SHOULD NOT be completed for those patients who are in acute renal failure. Acute renal failure is a condition in which kidney function can be expected to recover after a short period of dialysis, i.e., several weeks or months.

This form MUST BE completed within 45 days for ALL patients beginning any of the following:

Check the appropriate block that identifies the reason for submission of this form.

Initial For all patients who initially receive a kidney transplant instead of a course of dialysis. For patients for whom a regular course of dialysis has been prescribed by a physician because they have reached that stage of renal impairment that a kidney transplant or regular course of dialysis is necessary to maintain life. The first date of a regular course of dialysis is the date this prescription is implemented whether as an inpatient of a hospital, an outpatient in a dialysis center or facility, or a home patient.

The form should be completed for all patients in this category even if the patient dies within this time period.

Re-entitlement For beneficiaries who have already been entitled to ESRD Medicare benefits and those benefits were terminated because their coverage stopped 3 years post- transplant but now are again applying for Medicare ESRD benefits because they returned to dialysis or received another kidney transplant.

For beneficiaries who stopped dialysis for more than 12 months, have had their Medicare ESRD benefits terminated and now returned to dialysis or received a kidney transplant. These patients will be reapplying for Medicare ESRD benefits.

Supplemental Patient has received a transplant or trained for self-care dialysis within the first 3 months of the first date of dialysis and initial form was submitted.

All items except as follows: To be completed by the attending physician, head nurse, or social worker involved in this patient’s treatment of renal disease.

Items 15, 17-18, 26-27, 49-50: To be completed by the attending physician. Item 44: To be signed by the attending physician or the physician familiar with the patient’s self-care dialysis training. Items 54 and 55: To be signed and dated by the patient.

1. Enter the patient’s legal name (Last, first, middle initial).Name should appear exactly the same as it appears onpatient’s social security or Medicare card.

2. If the patient is covered by Medicare, enter his/her Medicareclaim number as it appears on his/her Medicare card.

3. Enter the patient’s own social security number. This numbercan be verified from his/her social security card.

4. Enter patient’s date of birth (2-digit Month, Day, and 4-digitYear). Example 07/25/1950.

5. Enter the patient’s mailing address (number and street orpost office box number, city, state, and ZIP code.)

6. Enter the patient’s home area code and telephone number.7. Check the appropriate block to identify sex.8. Check the appropriate block to identify ethnicity. Definitions

of the ethnicity categories for Federal statistics are as follows:Not Hispanic or Latino—A person of culture or origin notdescribed below, regardless of race.Hispanic or Latino—A person of Cuban, Puerto Rican, orMexican culture or origin regardless of race. Please completeItem 9 and provide the country, area of origin, or ancestry towhich the patient claims to belong.

9. Country/Area of origin or ancestry—Complete if informationis available or if directed to do so in question 8.

10. Check the appropriate block(s) to identify race. Definitions ofthe racial categories for Federal statistics are as follows:White—A person having origins in any of the original whitepeoples of Europe, the Middle East or North Africa.Black or African American—A person having origins in anyof the black racial groups of Africa. This includes native-bornBlack Americans, Africans, Haitians and residents of non-Spanish speaking Caribbean Islands of African descent.American Indian/Alaska Native—A person having origins inany of the original peoples of North America and SouthAmerica (including Central America) and who maintainsTribal affiliation or community attachment. Print the name ofthe enrolled or principal tribe to which the patient claims tobe a member.Asian—A person having origins in any of the original peoples of the Far East, Southeast Asia or the Indian subcontinentincluding, for example, Cambodia, China, India, Japan, Korea,Malaysia, Pakistan, the Philippine Islands, Thailand andVietnam.Native Hawaiian or Other Pacific Islander—A personhaving origins in any of the original peoples of Hawaii,Guam, Samoa, or other Pacific Islands. Please complete Item 9and provide the country, area of origin, or ancestry to whichthe patient claims to belong.

DISTRIBUTION OF COPIES: • Forward one copy of this form to the Social Security office servicing the claim.• Forward one copy of this form to the ESRD Network Organization.• Retain one copy of this form in the patient’s medical records file.According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number . The valid OMB control number for this information is 0938-0046. The time required to complete this information collection estimated to average 45 minutes per response, including the time to review instructions, search existing data resources, and gather the data needed, and complete and review the information collection. If you have any comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: CMS, Attention: PRA Reports Clearance Officer, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Please do not send applications, claims, payments, medical records or any documents containing sensitive information to the PRA Reports Clearance Office. Please note t h a t any correspondence not pe r ta in ing to the information collection burden approved under the associated OMB control number listed on this form will not be reviewed, forwarded, or retained. If you have questions or concerns regarding where to submit your documents, please contact 1-800-MEDICARE.

760

Form CMS‐2728‐U3 (08/15) 4

11. Check the appropriate yes or no block to indicate if patient is applying for ESRD Medicare. Note: Even though a personmay already be entitled to general Medicare coverage,he/she should reapply for ESRD Medicare coverage.

12. Check all the blocks that apply to this patient’s currentmedical insurance status.Medicaid—Patient is currently receiving State Medicaidbenefits.Medicare—Patient is currently entitled to Federal Medicarebenefits.Employer Group Health Insurance—Patient receives medicalbenefits through an employee health plan that covers employees, former employees, or the families of employees oformer employees.DVA—Patient is receiving medical care from a Department ofVeterans Affairs facility.Medicare Advantage—Patient is receiving medical benefitsunder a Medicare Advantage organization.Other Medical Insurance—Patient is receiving medicalbenefits under a health insurance plan that is not Medicare,Medicaid, Department of Veterans Affairs, HMO/M+C organization, nor an employer group health insurance plan.Examples of other medical insurance are Railroad Retirementand CHAMPUS beneficiaries.None—Patient has no medical insurance plan.

13. Enter the patient’s most recent recorded height in inches ORcentimeters at time form is being completed. If enteringheight in centimeters, round to the nearest centimeter.Estimate or use last known height for those unable to bemeasured. (Example of inches - 62. DO NOT PUT 5’2”) NOTE:For amputee patients, enter height prior to amputation.

14. Enter the patient’s most recent recorded dry weight inpounds OR kilograms at time form is being completed. Ifentering weight in kilograms, round to the nearest kilogram.

NOTE: For amputee patients, enter actual dry weight. 15. To be completed by the attending physician. Enter the

ICD10-CM Code to indicate the primary cause of end stagerenal disease.

16. Check the first box to indicate employment status 6 monthsprior to renal failure and the second box to indicate currentemployment status. Check only one box for each timeperiod. If patient is under 6 years of age, leave blank.

17. To be completed by the attending physician. Check all co- morbid conditions that apply.*Cerebrovascular Disease includes history ofstroke/cerebrovascular accident (CVA) and transient ischemic attack (TIA).*Peripheral Vascular Disease includes absent foot pulses,prior typical claudication, amputations for vascular disease,gangrene and aortic aneurysm.*Drug dependence means dependent on illicit drugs.

18. Prior to ESRD therapy, check the appropriate box to indicatewhether the patient received exogenous erythropoietin (EPO)or equivalent, was under the care of a nephrologist and/orwas under the care of a kidney dietitian. Provide vascularaccess information as to the type of access used (Arterio-Venous Fistula (AVF), graft, catheter (including port device)or other type of access) when the patient first receivedoutpatient dialysis. If an AVF access was not used, was amaturing AVF or graft present?

NOTE: For those patients re-entering the Medicare program after benefits were terminated, Items 19a thru 19c should contain initial laboratory values within 45 days prior to the most recent ESRD episode. Lipid profiles and HbA1c should be within 1 year of the most recent ESRD episode. Some tests may not be required for patients under 21 years of age.

19a1. Enter the serum albumin value (g/dl) and date test was taken. This value and date must be within 45 days prior to first dialysis treatment or kidney transplant.

19a2. Enter the lower limit of the normal range for serum albumin from the laboratory which performed the serum albumin test entered in 19a1.

19a3. Enter the serum albumin lab method used (BCG or BCP). 19b. Enter the serum creatinine value (mg/dl) and date test was

taken. THIS FIELD MUST BE COMPLETED. Value must be within 45 days prior to first dialysis treatment or kidney transplant.

19c. Enter the hemoglobin value (g/dl) and date test was taken. This value and date must be within 45 days prior to the first dialysis treatment or kidney transplant.

19d. Enter the HbA1c value and the date the test was taken. The date must be within 1 year prior to the first dialysis treatment or kidney transplant.

19e. Enter the Lipid Profile values and date test was taken. These values: TC–Total Cholesterol; LDL–LDL Cholesterol; HDL–HDL Cholesterol; TG–Triglycerides, and date must be within 1 year prior to the first dialysis treatment or kidney transplant.

20. Enter the name of the dialysis facility where patient iscurrently receiving care and who is completing this form forpatient.

21. Enter the 6-digit Medicare identification code of the dialysis facility in item 20.

22. If the person is receiving a regular course of dialysis treatment, check the appropriate anticipated long-termtreatment setting at the time this form is being completed.

23. If the patient is, or was, on regular dialysis, check theanticipated long-term primary type of dialysis:Hemodialysis, (enter the number of sessions prescribed perweek and the hours that were prescribed for each session),CAPD (Continuous Ambulatory Peritoneal Dialysis) and CCPD(Continuous Cycling Peritoneal Dialysis), or Other. Check onlyone block. NOTE: Other has been placed on this form to beused only to report IPD (Intermittent Peritoneal Dialysis) andany new method of dialysis that may be developed prior to therenewal of this form by Office of Management and Budget.

24. Enter the date (month, day, year) that a “regular course ofchronic dialysis” began. The beginning of the course ofdialysis is counted from the beginning of regularly scheduleddialysis necessary for the treatment of end stage renaldisease (ESRD) regardless of the dialysis setting. The date ofthe first dialysis treatment after the physician has determinedthat this patient has ESRD and has written a prescription fora “regular course of dialysis” is the “Date Regular Chronic Dialysis Began” regardless of whether this prescription was implemented in a hospital/ inpatient, outpatient, or homesetting and regardless of any acute treatments received priorto the implementation of the prescription.

NOTE: For these purposes, end stage renal disease means irreversible damage to a person’s kidneys so severely affecting his/her ability to remove or adjust blood wastes that in order to maintain life he or she must have either a course of dialysis or a kidney transplant to maintain life. If re-entering the Medicare program, enter beginning date of the current ESRD episode. Note in Remarks, Item 53, that patient is restarting dialysis. 25. Enter date patient started chronic dialysis at current facility of

dialysis services. In cases where patient transferred to currentdialysis facility, this date will be after the date in Item24.

26. Enter whether the patient has been informed of theiroptions for receiving a kidney transplant.

27. If the patient has not been informed of their options(answered “no” to Item 26), then enter all reasons why a

761

Form CMS‐2728‐U3 (08/15) 5

kidney transplant was not an option for this patient at this time.

28. Enter the date(s) of the patient’s kidney transplant(s). Ifreentering the Medicare program, enter current transplantdate.

29. Enter the name of the hospital where the patient received akidney transplant on the date in Item 28.

30. Enter the 6-digit Medicare identification code of the hospitalin Item 29 where the patient received a kidney transplant onthe date entered in Item 28.

31. Enter date patient was admitted as an inpatient to a hospitalin preparation for, or anticipation of, a kidney transplantprior to the date of the actual transplantation. This includes hospitalization for transplant workup in order to place thepatient on a transplant waiting list.

32. Enter the name of the hospital where patient was admittedas an inpatient in preparation for, or anticipation of, akidney transplant prior to the date of the actualtransplantation.

33. Enter the 6-digit Medicare identification number for hospitalin Item 32.

34. Check the appropriate functioning or non-functioning block.35. Enter the type of kidney transplant organ donor, Deceased,

Living Related or Living Unrelated, that was provided to thepatient.

36. If transplant is nonfunctioning, enter date patient returnedto a regular course of dialysis. If patient did not stop dialysis post-transplant, enter transplant date.

37. If applicable, check where patient is receiving dialysistreatment following transplant rejection. A nursing home orskilled nursing facility is considered as home setting

Self-dialysis Training Patients (Medicare ApplicantsOnly)Normally, Medicare entitlement begins with the third monthafter the month a patient begins a regular course of dialysis treatment. This 3-month qualifying period may be waived if apatient begins a self-dialysis training program in a Medicareapproved training facility and is expected to self-dialyzeafter the completion of the training program. Pleasecomplete items 38-43 if the patient has entered into a self- dialysis training program. Items 38-43 must be completed ifthe patient is applying for a Medicare waiver of the 3-monthqualifying period for dialysis benefits based on participation ina self-care dialysis training program.

38. Enter the name of the provider furnishing self-care dialysis training.

39. Enter the 6-digit Medicare identification number for thetraining provider in Item 38.

40. Enter the date self-dialysis training began.41. Check the appropriate block which describes the type of self-

care dialysis training the patient began. If the patient trainedfor hemodialysis, enter whether the training was to performdialysis in the home setting or in the facility (in center). If thepatient trained for IPD (Intermittent Peritoneal Dialysis),report as Other.

42. Check the appropriate block as to whether or not thephysician certifies that the patient is expected to completethe training successfully and self-dialyze on a regular basis.

43. Enter date patient completed or is expected to completeself-dialysis training.

44. Enter printed name and signature of the attending physicianor the physician familiar with the patient’s self-care dialysistraining.

45. Enter the Unique Physician Identification Number (UPIN) ofphysician in Item 44. (See Item 48 for explanation of UPIN.)

46. Enter the name of the physician who is supervising the

patient’s renal treatment at the time this form is completed. 47. Enter the area code and telephone number of the physician

who is supervising the patient’s renal treatment at the timethis form is completed.

48. Enter the physician’s UPIN assigned by CMS.A system of physician identifiers is mandated by Section 9202of the Consolidated Omnibus Budget Reconciliation Act of1985. It requires a unique identifier for each physician whoprovides services for which Medicare payment is made. Anidentifier is assigned to each physician regardless of his or herpractice configuration. The UPIN is established in a nationalRegistry of Medicare Physician Identification and EligibilityRecords (MPIER). Transamerica Occidental Life InsuranceCompany is the Registry Carrier that establishes andmaintains the national registry of physicians receiving PartMedicare payment. Its address is: UPIN Registry, TransamericaOccidental Life, P.O. Box 2575, Los Angeles, CA 90051-0575.

49. To be signed by the physician supervising the patient’s kidneytreatment. Signature of physician identified in Item 46. Astamped signature is unacceptable.

50. Enter date physician signed this form.51. To be signed by the physician who is currently following the

patient. If the patient had decided initially not to file anapplication for Medicare, the physician will be re-certifyingthat the patient is end stage renal, based on the samemedical evidence, by signing the copy of the CMS-2728 thatwas originally submitted and returned to the provider. If youdo not have a copy of the original CMS-2728 on file,complete a new form.

52. The date physician re-certified and signed the form.53. This remarks section may be used for any necessary

comments by either the physician, patient, ESRD Network orsocial security field office.

54. The patient’s signature authorizing the release ofinformation to the Department of Health and HumanServices must be secured here. If the patient is unable tosign the form, it should be signed by a relative, a personassuming responsibility for the patient or by a survivor.

55. The date patient signed form.

762

1. Patient’s Last Name First MI 2. Medicare Claim Number

3. Patient’s Sex 4. Date of Birth 5. Social Security Numbera. ■ Male b. ■ Female ■■ _ _ / _ _ / _ _ _ _

Month Day Year6. Patient’s State of Residence 7. Place of Death 8. Date of Death

a. ■ Hospital c. ■ Home e. ■ Other _ _ / _ _ / _ _ _ _ b. ■ Dialysis Unit d. ■ Nursing Home Month Day Year

9. Modality at Time of Deatha. ■ Incenter Hemodialysis b. ■ Home Hemodialysis c. ■ CAPD d. ■ CCPD e. ■ Transplant f. ■ Other

10. Provider Name and Address (Street) 11. Provider Number

Provider Address (City/State)

12. Causes of Death (enter codes from list on back of form)

a. Primary Cause _ _ _b. Were there secondary causes?

■ No

■ Yes, specify: _ _ _ _ _ _ _ _ _ _ _ _C. If cause is other (98) please specify:___________________________________________________________________■■

■ ■■■ ■■■ ■■■13. Renal replacement therapy discontinued prior to death: ■ Yes ■ No

If yes, check one of the following:a. ■ Following HD and/or PD access failure

b. ■ Following transplant failure

c. ■ Following chronic failure to thrive

d. ■ Following acute medical complication

e. ■ Other

f. Date of last dialysis treatment _ _ / _ _ / _ _ _ _ ■■ ■■ ■■■■

15. If deceased ever received a transplant:a. Date of most recent transplant _ _ / _ _ / _ _ _ _ ■ Unknown

b. Type of transplant received■ Living Related ■ Living Unrelated ■ Deceased ■ Unknown

c. Was graft functioning (patient not on dialysis) at time of death?■ Yes ■ No ■ Unknown

d. Did transplant patient resume chronic maintenance dialysis prior to death?■ Yes ■ No ■ Unknown

17. Name of Physician (Please print complete name) 18. Signature of Person Completing This Form Date

This report is required by law (42, U.S.C. 426; 20 CFR 405, Section 2133). Individually identifiable patient information will not be disclosed except as provided for in the Privacy Act of 1974 (5 U.S.C. 5520; 45 CFR Part 5a).

ESRD DEATH NOTIFICATIONEND STAGE RENAL DISEASE MEDICAL INFORMATION SYSTEM

DEPARTMENT OF HEALTH AND HUMAN SERVICES Form ApprovedCENTERS FOR MEDICARE & MEDICAID SERVICES OMB No. 0938-0448

14. Was discontinuation of renal replacementtherapy after patient/family request to stopdialysis?

■ Yes ■ No

■ Unknown ■ Not Applicable

Month Day Year

16. Was patient receiving Hospice care priorto death?

■ Yes ■ No

■ Unknown

Month Day Year

Month Day Year

Form CMS-2746-U2 (08/06) EF 08/2006

763

CARDIAC23 Myocardial infarction, acute25 Pericarditis, incl. Cardiac tamponade26 Atherosclerotic heart disease27 Cardiomyopathy28 Cardiac arrhythmia29 Cardiac arrest, cause unknown30 Valvular heart disease31 Pulmonary edema due to exogenous fluid32 Congestive Heart Failure

VASCULAR35 Pulmonary embolus36 Cerebrovascular accident including

intracranial hemorrhage37 Ischemic brain damage/Anoxic encephalopathy38 Hemorrhage from transplant site39 Hemorrhage from vascular access40 Hemorrhage from dialysis circuit41 Hemorrhage from ruptured vascular aneurysm42 Hemorrhage from surgery (not 38, 39, or 41)43 Other hemorrhage (not 38-42, 72)44 Mesenteric infarction/ischemic bowel

INFECTION33 Septicemia due to internal vascular access34 Septicemia due to vascular access catheter45 Peritoneal access infectious complication, bacterial46 Peritoneal access infectious complication, fungal47 Peritonitis (complication of peritoneal dialysis)48 Central nervous system infection (brain abscess,

meningitis, encephalitis, etc.)51 Septicemia due to peripheral vascular disease,

gangrene52 Septicemia, other61 Cardiac infection (endocarditis)62 Pulmonary infection (pneumonia, influenza)63 Abdominal infection (peritonitis (not comp of PD),

perforated bowel, diverticular disease, gallbladder)70 Genito-urinary infection (urinary tract infection,

pyelonephritis, renal abscess)

LIVER DISEASE64 Hepatitis B71 Hepatitis C65 Other viral hepatitis66 Liver-drug toxicity67 Cirrhosis68 Polycystic liver disease69 Liver failure, cause unknown or other

GASTRO-INTESTINAL72 Gastro-intestinal hemorrhage73 Pancreatitis75 Perforation of peptic ulcer76 Perforation of bowel (not 75)

METABOLIC24 Hyperkalemia77 Hypokalemia78 Hypernatremia79 Hyponatremia

100 Hypoglycemia101 Hyperglycemia102 Diabetic coma95 Acidosis

ENDOCRINE96 Adrenal insufficiency97 Hypothyroidism

103 Hyperthyroidism

OTHER80 Bone marrow depression81 Cachexia/failure to thrive82 Malignant disease, patient ever on

Immunosuppressive therapy83 Malignant disease (not 82)84 Dementia, incl. dialysis dementia, Alzheimer’s85 Seizures87 Chronic obstructive lung disease (COPD)88 Complications of surgery89 Air embolism

104 Withdrawal from dialysis/uremia 90 Accident related to treatment91 Accident unrelated to treatment92 Suicide93 Drug overdose (street drugs)94 Drug overdose (not 92 or 93)98 Other cause of death99 Unknown

ESRD DEATH NOTIFICATION FORMLIST OF CAUSES

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number.The valid OMB control number for this information collection is 0938-0448. The time required to complete this information collection is estimated to average 30minutes per response, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the informationcollection. If you have any comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: CMS, Attn: PRAReports Clearance Officer, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.

Form CMS-2746-U2 (08/06) EF 08/2006

764

Hemodialysis Patients DialyzingMore Than 4 Times Per Week

Incenter Dialysis Treatments(Include Training Treatments)

Patient Eligibility StatusEnd of Survey Period

This report is required by law (42 USC 426; 42 CFR 405.2133). Individually identifiable patient information will not be disclosed except as provided for in the Privacy Act of 1974(5 USC 5520; 45 CFR, Part 5a).

REMARKS REGARDING INFORMATION PROVIDED ON THIS SURVEY SHOULD BE ENTERED ON THE LAST PAGE OF THE SURVEY

Losses During Survey Period

DIALYSIS PATIENTS

DIALYSIS PATIENTS AND TREATMENTS

END STAGE RENAL DISEASE MEDICAL INFORMATION SYSTEMESRD FACILITY SURVEY (DIALYSIS UNITS ONLY)

Additions During Survey Period

Startedfor first

time ever

Restarted

Trans-ferredfromother

dialysisunit

Returnedafter

transplan-tation

In-center

Home

TotalFields 01thru 02

Home

Patients Receiving CareBeginning of Survey Period

DeathsRecov-

eredkidney

function

Receivedtrans-plant

Trans-ferred to

other dial-ysis unit

Dis-continueddialysis

Other(LTFU)

Currentlyenrolled

inMedicare

Non-Medicare

Medicareapplica-

tionpending

TREATMENT AND STAFFING

Hemo-Dialysis

Other Hemo-Dialysis

CAPD CCPD Other Fields 14thru 19

Hemo-Dialysis

CAPD CCPD Other Fields 21thru 24

Patients Receiving Care at End of Survey Period

IncenterDialysis

Self-Dialysis TrainingTotal

IncenterDialysis

Home DialysisTotalHome

Dialysis

Fields 20and 25

TotalPatients

Hemodialysis Other

Form CMS-2744A (02/04)

DEPARTMENT OF HEALTH AND HUMAN SERVICESCENTERS FOR MEDICARE & MEDICAID SERVICES

COMPLETED BY (Name) DATE TITLE TELEPHONE NO.

FOR THE PERIOD

01 02 03 04A04B

05A05B

06A06B

07A07B

08A08B

09A09B

10A10B

11A11B

12A12B

13A13B

14 15 16 17 18 19 20 21 22 23 24 25 26

27 28 29

30A30B

31A31B

37

Form ApprovedOMB No. 0938-0447

Incenter

Setting Day Nocturnal

Incenter

Home

Facility Physical Address(If different than mailing address) Suite/Room Street City State/Zip Code

Number of Dialysis Stations: Facility Telephone: ( )

Facility Ownership Type: Profit Non-Profit

Facility Local/National Affiliation/Chain Information(i.e. Gambro, etc.)

Types of dialysis services offered:

Incenter Hemodialysis Peritoneal Dialysis Home Hemodialysis Training

Does your facility offer a dialysis shift that starts at 5:00 p.m. or later?

Yes No

Patientsaged 18

through 54

PatientsEmployedfull-time orpart-time

Patientsreceivingservicesfrom VocRehab

32 33 34

Patientsattending

schoolfull-time orpart-time

35

Vocational Rehabilitation

36

Staffing

a. RNsb. LPN/LVNsc. PCTsd. APNse. Dietitiansf. Social Workers

3938 4140

Number of Staff Number of Open Pos.

Position Full Time Part Time Full Time Part Time

765

Dialysis

This report is required by law (42 USC 426; 42 CFR 405.2133). Individually identifiable patient information will not be disclosed except as provided for in the Privacy Act of 1974(5 USC 5520; 45 CFR, Part 5a).

Eligibility Status of PatientsTransplanted at this FacilityDuring the Survey Period

PATIENTS TRANSPLANTEDAND DONOR TYPE

KIDNEY TRANSPLANTS PERFORMED

END STAGE RENAL DISEASE MEDICAL INFORMATION SYSTEMESRD FACILITY SURVEY (TRANSPLANT CENTERS ONLY)

Patientswho

receivedtransplant

at thisfacility

Currentlyenrolled

inMedicare

REMARKS/COMMENTS

Form CMS-2744B (02/04)

COMPLETED BY (Name) DATE TITLE TELEPHONE NO.

FOR THE PERIOD

42

Form ApprovedOMB No. 0938-0447

Medicareapplica-

tionpending

Non-Medicare

OtherU.S. Res.

43 44 45 46

Transplant Procedures Performedat This Facility

LivingRelatedDonor

LivingUnrelated

DonorDeceased

Donor

TotalFields 47thru 49

47 48 49 50

Patients AwaitingTransplant

Nondialysis

51 52

TO BE COMPLETED BYKIDNEY TRANSPLANT CENTERS ONLY

DEPARTMENT OF HEALTH AND HUMAN SERVICESCENTERS FOR MEDICARE & MEDICAID SERVICES

766

D) Kidney transplant activity: This is meant to be a count of transplants, nottransplanted patients. If a patient receives multiple transplants during the year,all should be counted. If you report only transplanted patients, please providethese numbers and note that they refer to patients. D.1 (deceased donor[cadaveric] transplants), D.2 (living donor transplants), and D.3 (unknown donortype) should sum to the total number of transplants.

A) Population: the total general population of your country for theyears that ESRD data will be provided.

C.4) All patients treated with in-center hemodialysis as of December 31 of theindicated year.

B.1) Incidence: the count of patients who start any form of renalreplacement therapy during the year. These are first-time patientsonly; patients who start dialysis after a failed transplant, for example,should not be included.

C.2) Patients with a functioning kidney transplant as of December 31for the indicated year.

C.5) All patients treated with CAPD, APD, or IPD as of December 31 of theindicated year.

C.6) All patients treated with home hemodialysis as of December 31.

B.2) The subset of total incident patients whose failure is due todiabetic nephropathy. Subtracting B2 from B1 should give the totalnumber of incident patients for all non-diabetic nephropathy causes.

C) Prevalence: the point prevalent count of patients at the end of thecalendar year (December 31).

C.1) All patients on some form of ESRD treatment: dialysis and kidneytransplantation.

C.3) All dialysis patients. C.2. and C.3. should sum to C.1. unless there are lost-to-follow-up patients. If there are lost-to-follow-up patients, please note this factand whether these patients are captured in C.2.

United States Renal Data System (USRDS)International Data Collection Form

This form is designed to solicit information on the population of End-Stage Renal Disease (ESRD) patients in your country who are receiving renal replacement therapy (RRT). The information you provide will be returned to you along with comparable information from other countries participating in this voluntary effort.

If data are not available for all years, please include data for the most recent year(s). If you cannot provide data in the age and sex categories listed, please provide the total numbers. The format has been created to more clearly separate incident and prevalent population counts from transplant counts.

767

Country/Region* Year Female Male 0-19 20-44 45-64 65-74 75+ Unknown Total20122013201420152016



Number of People by Age Category

B.2) Incidence of ESRD Renal Replacement Therapy Due to Diabetes

Population: the total general population of your country for the years indicated, or most recent available.A) Total General Population of the Country/Region

Number by Sex

Indicate the subset of incident patients who started any form of renal replacement therapy during the year and their ESRD was due to diabetic nephropathy.Subtracting B.2 from B.1 should equal the total number of incident patients for all non-diabetic nephropathy causes.

Incidence: the count of patients who start any form of renal replacement therapy during the year. These are first-time patients only; patients who start dialysis aftera failed transplant, for example, should not be included.

B.1) Incidence of ESRD Renal Replacement Therapy

Number by Sex Number of People by Age Category


768




C.1) Prevalence: Total Number of ESRD Patients Receiving Renal Replacement Therapy (All Treatment Categories) at the End ofthe Year (December 31)Please include all patients receiving either dialysis or living with a kidney transplant for ESRD treatment at end of year.

Number by Sex

Please list all patients receiving dialysis at end of year for ESRD therapy. C.2 and C.3 should sum to C.1 unless there are lost-to-follow-up patients. If there are lost-to-follow-up patients, please note this fact and whether these patients are captured in C.2.


Number by Sex


Please include all patients living with a functioning kidney transplant at end of the year for treatment of ESRD.

C.3) Prevalence: Total Number of ESRD Patients on Dialysis at End of the Year (December 31)

C.2) Prevalence: Total Number of ESRD Patients with a Functioning Kidney Transplant at the End of the Year (December 31)


769




Please indicate all patients treated with home hemodialysis at the end of each year.C.6) Prevalence: Total Number of ESRD Patients on Home Hemodialysis at the End of the Year (December 31)




Please include all patients treated with continuous ambulatory peritoneal dialysis, automated peritoneal dialysis, or intermittent peritoneal dialysis for ESRD therapyat the end of each year.

C.5) Prevalence: Total Number of ESRD Patients on CAPD, APD, or IPD at the End of the Year (December 31)

C.4) Prevalence: Total Number of ESRD Patients on In-Center Hemodialysis at the End of the Year (December 31)

Number by Sex

Please include all patients treated with in-center hemodialysis for ESRD therapy at the end of each year.

770




D.2) Transplant: Total Number of Living Donor Kidney Transplants During the Year

Please indicate the total number of deceased donor (cadaveric) kidney transplantations performed during the year.

Number by Sex Number of Transplants by Age Category

D.1) Transplant: Total Number of Deceased Donor (Cadaveric) Kidney Transplants During the Year



Indicate the total number of kidney transplantations performed during the year in which it was unknown whether the transplant was a deceased (cadaveric) or livingdonor kidney transplant.

Please indicate the total number of living donor kidney transplantations performed during the year.

D.3) Transplant: Total Number of Kidney Transplants During the Year with Unknown Donor Type

*Please note if data is representative of the whole country or individual regions

771

usrds annual data report appendices, 2018...glossary acute kidney injury (aki) also known as acute...

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